-- MediBeacon and Huadong Medicine will collaboratively work to reach regulatory approval on MediBeacon's entire portfolio of assets in Greater China
MediBeacon Inc. , whose largest shareholder is Pansend Life Sciences, LLC, a subsidiary of HC2 Holdings, Inc. (NYSE MKT: HCHC), announced today that they have entered into a definitive agreement with Huadong Medicine, a publicly traded company on the Shenzhen Stock Exchange. The agreement will provide exclusive rights to MediBeacon's portfolio of assets in Greater China. Huadong Medicine will be responsible to fund the clinical trials, commercial and regulatory activities in 25 Asian countries including Greater China (PRC Mainland China, Hong Kong, Macau, Taiwan), Thailand, Vietnam, Indonesia, Philippines and Singapore.
MediBeacon's Transdermal Glomerular Filtration Rate Measurement System (TGFR) is poised to begin its Pivotal trial in the U.S. and Europe. The TGFR is designed to measure kidney function at the point of care without the need for blood sampling or urine collection. The U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the TGFR in 2018.[1] MediBeacon's agents and devices are not approved for human use by any regulatory agency.
It is estimated that 10.8% of the people in China suffer from Chronic Kidney Disease (CKD).[2] Kidney disease is a "hidden epidemic" affecting more than 850 million people worldwide.[3] The ability to measure GFR is of high clinical interest especially in patients with, or at risk of, kidney disease.
Under terms of the deal, MediBeacon will receive an initial $15 million equity payment at a pre-money valuation of $300 million and a second $15 million equity payment upon achieving U.S. FDA approval for the TGFR at a pre-money valuation of $400 million. Huadong Medicine will fund all commercial and regulatory activities in Greater China and select Asian countries. In addition, MediBeacon will receive royalty payments on net sales in the specified countries.
"We are extremely excited to partner with Huadong Medicine in Greater China," says Steve Hanley, CEO and Co-Founder of MediBeacon. "Huadong has over 6,500 representatives covering all key areas of China including a strong presence in the nephrology community. As a leading pharmaceutical company in China, we believe they are the perfect partner to drive market adoption for our pipeline of products."
As part of this transaction, Richard B. Dorshow, PhD, Chief Scientific Officer and Co-Founder of MediBeacon Inc., will assume the role of Special Scientific Advisor to Huadong Medicine.
MediBeacon's fluorescent agent platform for use in physiological function monitoring has important applications beyond the field of kidney health. The Company's Transdermal Gastrointestinal Permeability System has been supported by multiple grants from the Bill & Melinda Gates Foundation. In addition, the company has just completed initial pre-clinical studies evaluating use of its agents in imaging the vasculature of the eye.
About MediBeacon Inc.
MediBeacon's mission is to commercialize biocompatible optical diagnostic agents for physiological monitoring, surgical guidance, and imaging of pathological disease in the human population. Several product concepts in these arenas are contained in the MediBeacon Intellectual Property estate. MediBeacon's portfolio includes a renal function system that uses an optical skin sensor combined with a proprietary fluorescent tracer agent that glows in the presence of light. This system, currently in human trials, is designed to enable clinically practical point of care measurement of a patient's kidney function.
